Recall Z-1639-2010 ยท FPA Set, Administration, Intravascular
Churchill Medical Systems, Inc.
Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. Intravascular administration set.
| Date | May 21, 2010 (initiated Oct 20, 2009) |
| Status | Terminated |
| Reason | Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents |
| Root cause | Process change control |
| Action | Churchill Medical Systems issued an "Urgent: Product Advisory Customer Notification" dated October 20, 2009 requesting return of affected product and notification to end users. For further information, contact Churchill Medical Systems at 1-603-743-5988 or via fax at 1-603-743-6328. |
| Quantity | 283,900 each |
| Distribution | Distributed to Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK Churchill Medical Systems, Inc., Jun 12, 2001 |